Effective GMP Compliance: Ensuring Quality Control in Pharmaceutical Manufacturing
In the manufacturing sector, GMP, or Good Manufacturing Practices, is more than just a buzzword. It’s a set of protocols and operations that should be company doctrine for all businesses involved in the pharmaceutical manufacturing, testing, and release of end-user products. Find out how to implement and enforce GMP compliance and promote quality control. The […]
Transform Your TMF Management With A Validated LMS
The clinical phase accounts for 69% of overall R&D costs, resulting in a need to try to reduce costs. An area that can keep a trial on track both time-wise and financially is addressing delays due to compliance inadequacies. In other words, effectively managing your Trial Master File (TMF) can mean the difference between trial […]
Ensuring 21 CFR Part 11 Compliance With Dokeos: A Guide For Quality Control
Since its introduction in 1997, the FDA’s 21 CFR Part 11 has provided rules on the management of electronic records and electronic signatures in the pharmaceutical and biotechnology industries. The latest update was published on October 1, 2024. It provides a guide to using electronic records in clinical investigations, helping stakeholders adhere to good clinical […]
Strengthening Pharma Compliance: CAPA Training for Quality Standards
Corrective action and preventive action, or CAPA, is an organizational method for identifying, investigating, and resolving issues that may manifest during a product development, testing, or release phase. Pharma manufacturing and medical device industries are mandated to have a CAPA plan in place under the Food and Drug Administration (FDA) and International Organization for Standardization […]
Streamlining FDA Compliance Training for Pharmaceutical Companies
U.S. pharmaceutical companies are regulated by the Food and Drug Administration (FDA). It oversees every step of the process, from the manufacturing to the advertising of drugs and medical devices. This makes pharmaceutical training on FDA compliance critical. Failure to comply can result in hefty fines, reputational damage, and civil lawsuits. Give your staff the […]
Navigating HIPAA Compliance: Pharmaceutical Best Practices
Under provision §160.103, any health sector involved in the “sale or dispensing of a drug, device, or equipment,” is subject to HIPAA laws. This entails the pharmaceutical industry, even those based overseas if they serve U.S. clients and exchange information electronically. Compliance isn’t always easy in practice, especially with the seemingly endless page-after-page of formal […]
Safety and Compliance training in Pharmaceutical Manufacturing
GmP guidelines establish compliance and safety standards for work floor operations and product quality assurance. The regulations are set by governing bodies like the World Health Organization (WHO) and the Pharmaceutical Inspection Cooperation Scheme (PIC/S). The guidelines are extensive and can be cumbersome to navigate. Fortunately, training in pharmaceutical manufacturing can be managed on a […]
How Dokeos Complies with 21 CFR Part 11
21 CFR Part 11 establishes electronic record-keeping regulations for food-processing and pharmaceutical industries. The provisions fall under the Food and Drug Administration under the organization’s Title 21 Code of Federal Regulations. The best way to ensure compliance is via a SaaS platform that follows the regulations to a T, therefore ensuring your company is within […]
Boosting Productivity: Integrating LMS with HR Workflows
Boosting productivity should be at the core of every HR corporate resolution plan. Employees who are productive and maximize their time on the clock impact the company’s bottom line, directly or indirectly. LMS as part of a broader digital adoption initiative can be a significant game-changer in positively changing employee attitudes, confidence, and productivity. Learn […]
Mastering GxP Compliance: Elevate Your Team with GxP Training
Most industries have their respective GxP compliance, such as GMP for the manufacturing sector, GLP for science laboratories, etc. Whichever your niche falls under, proficient knowledge in this area is non-negotiable. Failure to comply from even just a single employee can have devastating consequences, ranging from fines to PR damage. Fortunately, GxP compliance training doesn’t […]
